MAUDE Adverse Event Report: EDWARDS LIFESCIENCES ALTERRA ADAPTIVE PRESTENT SYSTEM; PULMONARY VALVE PROTHESIS, PERCUTANEOUSLY DELIVERED

Model Number	29AP4045A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There is one type 1 fracture found at the inflow in the 1 year flr submission # (b)(4) for (b)(4).Upon retrospective review of the 30-day cxr submission for (b)(4), one fracture was found at the alterra inflow.This was found retrospectively with knowledge of the 1 year flr.
Additional Manufacturer Narrative
The investigation is ongoing.
Additional Manufacturer Narrative
Correction to the b5 description.Correction to h6; component code, type of investigation, investigation findings, investigation conclusion.The alterra adaptive prestent was not returned for examination.Due to the unavailability of the complaint device, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.A device history record (dhr) review was performed and did not reveal any manufacturing nonconformance issues that would have contributed to the event.A lot history review was performed and revealed other complaints relating to the complaint code.The following instructions were reviewed: edwards alterra adaptive prestent system.Based on this review, no ifu training deficiencies were identified.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of this adverse event is not required at this time.The reported event of a strut fracture was confirmed empirically based on the 1-year flr and 30-day cxr submissions.A review of the dhr and lot history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint event.Additionally, a review of ifu/training materials revealed no deficiencies.An in-depth evaluation related to alterra prestent fracture has been documented in technical summary.As such, the potential fracture on the proximal end of the frame could be attributed to the conditions of the patient's anatomy.While a conclusive root cause is unable to be determined, available information suggests that patient factors (rvot characteristics) may have contributed to the complaint event.A product risk assessment has previously been initiated to assess the risks associated with the failure mode.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.
Event or Problem Description
As reported by the encircle clinical trial, upon retrospective review of the 30-day chest x-ray, one fracture was found at the alterra inflow.This was found retrospectively with knowledge of the 1-year flr.

• Brand Name: ALTERRA ADAPTIVE PRESTENT SYSTEM
• Common Device Name: PULMONARY VALVE PROTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 19300532
• Report Number: 2015691-2024-03555
• Device Sequence Number: 6834053
• Product Code: NPV
• UDI-Device Identifier: 00690103210866
• UDI-Public: (01)00690103210866(17)240306(11)220302
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P200015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/06/2024
• Device Model Number: 29AP4045A
• Device Lot Number: 64236180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2024
• Supplement Date Received by Manufacturer: 06/18/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown